Gandiv Insights LLC · 13 hours ago
Design Quality Engineer – Pharmaceuticals
Cambridge, MA
Contract
Onsite
Senior Level
5+ years expGandiv Insights LLC is seeking a Design Quality Engineer to support pharmaceutical product development activities. This role ensures compliance with FDA regulations and quality processes throughout the product lifecycle while working cross-functionally to maintain design documentation.
Information Technology & Services
Responsibilities
Support design control activities including design reviews, risk assessments, and DHF documentation
Ensure compliance with FDA regulations (21 CFR 210/211) and applicable quality standards
Review and approve design-related documentation, change controls, and validation deliverables
Support technology transfer and collaborate with Manufacturing and Regulatory teams
Participate in audits and regulatory inspections as required
Qualification
Required
Bachelor's degree in Engineering or Life Sciences
5+ years of design quality engineering experience in pharma or combination products
Strong knowledge of cGMP, FDA regulations, and risk management
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase